Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva as an alternative specimen for HIV testing has been explored. Today, very sensitive tests have been formulated and have been used for diagnosing HIV in adults and older children. OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as well test the saliva.

Most studies done on the use of saliva have been carried out in adults and have produced very good results. However very few such studies have been done in children, especially infants. In adults, use of saliva has also highlighted the advantages of ease of collection and increased acceptability of testing.

HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine test and oral fluid testing is more acceptable than blood testing.

Sensitivity and specificity of the OraQuick rapid test [ Time Frame: one year ]

Secondary Outcome Measures:

Acceptance of HIV testing using oral fluid [ Time Frame: one year ]

Enrollment:

1000

Study Start Date:

December 2006

Study Completion Date:

September 2007

Intervention Details:

Other: Abbott-rapid HIV antibody test

Abbott will be used to test serum or whole blood

Other: OraQuick Rapid HIV-1/2 Antibody test

OraQuick for oral fluid HIV antibody testing

Detailed Description:

BACKGROUND Serological identification of antibodies to Human Immunodeficiency virus (HIV) in blood is the most widely used method to screen for HIV infection. Use of oral fluid as an alternative to blood sample has been studies the past 20 years and extremely sensitive tests that are able to detect the very low quantities of antibodies found in oral fluid have been formulated and are currently being used. OraQuick rapid test, a combination, collection and testing device that uses both blood and oral fluid was approved for used by the U.S.A, FDA in 2002 and has been tested in adults and older children.

The value of oral fluid in screening for HIV infection in adults is now well established and has been used extensively in field survey and epidemiologic studies. However, these methods have not been studied in children in whom differences in test performance might be expected. Studies in adults have also highlighted the advantages of oral fluid testing, such as ease of collection and high degree of acceptability of testing. This would make oral fluid testing a good alternative for HIV screening in infants, a challenging population in which venipuncture is often difficult or unacceptable.

Eligibility

Ages Eligible for Study:

up to 18 Months (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses and aged less than 18 months old

Criteria

Inclusion Criteria:

Children aged less than 18 months

Admission to the Department of Pediatrics for any condition

Consent from caregiver for HIV testing using both oral fluid and blood r

Exclusion Criteria:

Age of more than 18 months

Refusal of consent by caregiver

Outpatients

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378118